研究倫理審査委員による看護学研究の倫理審査に関する認識と課題

Perceptions and challenges regarding ethical review of nursing research by ethics review committee members

　看護学研究の倫理審査に関しては、多くの課題の存在が指摘されているが、全国的な調査は行われていない。本研究の目的は、審査を行う側が看護学研究の倫理審査について、認識している現状と課題、望ましいあり方について明らかにすることである。全国の看護系大学90校の倫理審査委員会委員長と委員を対象に質問紙調査を実施、231名から回答を得た。現状に関しては、外部委員の不在等指針から逸脱している大学があることのほか、必要書類の不備、研究倫理の理解不足など申請者側の課題、委員に対する研修が必要など審査側の課題とともに、組織の取り組みに関する課題が明らかとなった。また、審査のあり方としては研究を支援する立場と考える人が半数を超えたが、審査基準があっても判断に迷う委員も多かった。委員会や審査のあり方は各大学の独自性を反映したものとなろうが、研究倫理に関する最新の情報の提供や各大学における工夫などはもっと共有されてよい。

　While many challenges exist, there has not been a nationwide survey on ethical review of nursing research. This study aimed to reveal opinions of ethics committee members about the actual state of ethical review processes, as well as what the ethical review process should entail. A questionnaire was administered to chairpersons and members of research ethics committees in 90 universities with nursing departments. A total of 231 responses were obtained. Results of the survey revealed that some committees have no outside members, which is against the guideline. Regarding applicants, there were issues such as the lack of research ethics in some applicants, and that some application forms are incomplete. As for committee members, there appeared to be a need to implement training. Regarding universities, efforts are required to improve ethical review processes. More than half of the respondents thought that ethical review should be conducted in a way that supports researchers in carrying out their studies, while many of them experienced difficulty in making decisions. Although ethics committees and review processes differ from university to university, it is recommended that the latest information on research ethics and how to operate ethics committees be shared among universities.